Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates zur Schaffung eines Rahmens für die Stärkung der Verfügbarkeit von und der Sicherheit der Versorgung mit kritischen Arzneimitteln sowie der Verfügbarkeit und der Zugänglichkeit von Arzneimitteln von gemeinsamem Interesse und zur Änderung der Verordnung (EU) 2024/795 (Text von Bedeutung für den EWR) (19880/EU XXVIII.GP)

Linkart	Link
COM Kommission	COM(2019) 196
COM Kommission	COM(2023) 192
COM Kommission	COM(2023) 193
INT Interinstitutionelle Zahl	2025/0102 (COD)
ABL Amtsblatter	ABl. L 107 vom 26.3.2021
ABL Amtsblatter	ABl. L 107 vom 26.3.2021, S. 1
ABL Amtsblatter	ABl. L 166 vom 11.5.2021, S. 1
ABL Amtsblatter	ABl. L 170 vom 12.5.2021, S. 1
ABL Amtsblatter	ABl. L 197 vom 21.7.2001, S. 30
ABL Amtsblatter	ABl. L 197 vom 24.7.2012, S. 1
ABL Amtsblatter	ABl. L 20 vom 26.1.2010, S. 7
ABL Amtsblatter	ABl. L 20 vom 31.2.2022, S. 1
ABL Amtsblatter	ABl. L 206 vom 22.7.1992, S. 7
ABL Amtsblatter	ABl. L 257 vom 28.8.2014, S. 135
BES Beschlusse	Nr. 1082/2013/EU
BES Beschlusse	2003/87/EG
BES Beschlusse	2015/2240
BES Beschlusse	2016/296
BES Beschlusse	2016/369
BES Beschlusse	2021/1056
BES Beschlusse	2021/1057
BES Beschlusse	2021/1058
BES Beschlusse	2021/1060
BES Beschlusse	2021/241
RIL Richtlinien	(EU) 2022/2555
RIL Richtlinien	2000/60/EG
RIL Richtlinien	2001/42/EG
RIL Richtlinien	2003/87/EG
RIL Richtlinien	2004/18/EG
RIL Richtlinien	2008/98/EG
RIL Richtlinien	2009/147/EG
RIL Richtlinien	2010/75/EU
RIL Richtlinien	2011/24/EU
RIL Richtlinien	2011/92/EU
VER Verordnungen	1082/2013
VER Verordnungen	1290/2013
VER Verordnungen	1291/2013
VER Verordnungen	1303/2013
VER Verordnungen	1394/2007
VER Verordnungen	141/2000
VER Verordnungen	1901/2006
VER Verordnungen	2003/87
VER Verordnungen	2004/18
VER Verordnungen	2014/24

Datum	EU-Datenbanknr.	Dokument der EU-Vorlage	Sprache	Einstufung
11.03.2025	14241/EU XXVIII.GP	COM: COM(2025) 102 final PDF	englisch	PUBLIC	EU-Vorlage Verordnungsentwürfe Proposal for a Regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 (Text with EEA relevance) Eingelangt am 12.03.2025, Europäische Kommission - Österr. Parlament

Interinstitutionelle Zahl Der Link führt zu den einzelnen Dokumenten dieses Vorhabens.	Link
2025/0102 COD	Legislative Observatory

Thema
Gesundheitswesen

Datum	Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Art	Betreff
12.05.2025	COM: D(2025) 5737	EUUS Übermittlungsschreiben	Übermittlungsschreiben/COM(2025) 102/Fristbeginn: 12. Mai 2025 (20070/EU XXVIII.GP)
19.06.2025	RAT: 10597/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Spanish parliament (Cortes Generales) (25336/EU XXVIII.GP)
19.06.2025	RAT: 10600/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Swedish Riksdag (25416/EU XXVIII.GP)
25.06.2025	RAT: 10807/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Italian Chamber of Deputies (26090/EU XXVIII.GP)
25.06.2025	RAT: 10808/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Czech Senate (26097/EU XXVIII.GP)
27.06.2025	RAT: 10943/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Romanian Senate (26402/EU XXVIII.GP)
10.07.2025	RAT: 11454/25	EUNP Stellungnahmen nationaler Parlamente	Proposal for a Regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795/2025/0102 (COD)/Cover note from the French Senate (28248/EU XXVIII.GP)
16.07.2025	RAT: 11666/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025) 102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Italian Senate (29004/EU XXVIII.GP)
30.07.2025	RAT: 11992/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality (30164/EU XXVIII.GP)
13.05.2025	RAT: CM 2768/25	EUCM EU-Vorlage: Kommunikationsdokument	Consultation of the European Economic and Social Committee by the Council on a proposal for a Regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [ref. 2025/0102 (COD) - COM(2025) 102 final - 6872/25 (20205/EU XXVIII.GP)
30.07.2025	RAT: 11992/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality (30164/EU XXVIII.GP)
25.06.2025	RAT: 10807/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Italian Chamber of Deputies (26090/EU XXVIII.GP)
25.06.2025	RAT: 10808/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Czech Senate (26097/EU XXVIII.GP)
27.06.2025	RAT: 10943/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Romanian Senate (26402/EU XXVIII.GP)
10.07.2025	RAT: 11454/25	EUNP Stellungnahmen nationaler Parlamente	Proposal for a Regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795/2025/0102 (COD)/Cover note from the French Senate (28248/EU XXVIII.GP)
16.07.2025	RAT: 11666/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025) 102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Italian Senate (29004/EU XXVIII.GP)
19.06.2025	RAT: 10597/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Spanish parliament (Cortes Generales) (25336/EU XXVIII.GP)
19.06.2025	RAT: 10600/25	EUST EU-Vorlage: Offizielles Ratsdokument	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 [6872/25 - COM(2025)102] - Opinion on the application of the Principles of Subsidiarity and Proportionality/Cover note from the Swedish Riksdag (25416/EU XXVIII.GP)
10.07.2025	RAT: 11454/25	EUNP Stellungnahmen nationaler Parlamente	Proposal for a Regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795/2025/0102 (COD)/Cover note from the French Senate (28248/EU XXVIII.GP)

Datum	Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Art	Betreff
12.03.2025	RAT: 6872/25	EUST EU-Vorlage: Offizielles Ratsdokument	Vorschlag für eine VERORDNUNG DES EUROPÄISCHEN PARLAMENTS UND DES RATES zur Schaffung eines Rahmens für die Stärkung der Verfügbarkeit von und der Sicherheit der Versorgung mit kritischen Arzneimitteln sowie der Verfügbarkeit und der Zugänglichkeit von Arzneimitteln von gemeinsamem Interesse und zur Änderung der Verordnung (EU) 2024/795 (19957/EU XXVIII.GP)

Dok.Nr. Dokumenten der EU-Institutionen zugeordnete, fortlaufende Nummer mit Jahreszahl, um diese eindeutig zu identifizieren.	Links
COM: COM(2025) 102	EUR-Lex IPEX

EU-V: Verordnungsentwürfe

EU-Vorlage Verordnungsentwürfe